Right data for right patient—a precisionFDA NCI–CPTAC Multi-omics Mislabeling Challenge
Boja, Emily, Težak, Živana, Zhang, Bing, Wang, Pei, Johanson, Elaine, Hinton, Denise, Rodriguez, Henry
Published in Nature medicine (01.09.2018)
Published in Nature medicine (01.09.2018)
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The first FDA marketing authorizations of next-generation sequencing technology and tests: challenges, solutions and impact for future assays
Bijwaard, Karen, Dickey, Jennifer S, Kelm, Kellie, Težak, Živana
Published in Expert review of molecular diagnostics (01.01.2015)
Published in Expert review of molecular diagnostics (01.01.2015)
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US FDA and personalized medicine: in vitro diagnostic regulatory perspective
Težak, Živana, Kondratovich, Marina V, Mansfield, Elizabeth
Published in Personalized medicine (01.09.2010)
Published in Personalized medicine (01.09.2010)
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The journey to regulation of protein-based multiplex quantitative assays
Boja, Emily S, Jortani, Saeed A, Ritchie, James, Hoofnagle, Andrew N, Težak, Živana, Mansfield, Elizabeth, Keller, Penny, Rivers, Robert C, Rahbar, Amir, Anderson, N Leigh, Srinivas, Pothur, Rodriguez, Henry
Published in Clinical chemistry (Baltimore, Md.) (01.04.2011)
Published in Clinical chemistry (Baltimore, Md.) (01.04.2011)
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Biomarkers to improve the benefit/risk balance for approved therapeutics: a US FDA perspective on personalized medicine
Sapsford, Kim E, Tezak, Zivana, Kondratovich, Marina, Pacanowski, Michael A, Zineh, Issam, Mansfield, Elizabeth
Published in Therapeutic delivery (01.11.2010)
Published in Therapeutic delivery (01.11.2010)
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Characterization of whole genome amplified (WGA) DNA for use in genotyping assay development
Han, Tao, Chang, Ching-Wei, Kwekel, Joshua C, Chen, Ying, Ge, Yun, Martinez-Murillo, Francisco, Roscoe, Donna, Težak, Zivana, Philip, Reena, Bijwaard, Karen, Fuscoe, James C
Published in BMC genomics (01.06.2012)
Published in BMC genomics (01.06.2012)
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FDA perspectives on potential microarray-based clinical diagnostics
Tezak, Zivana, Ranamukhaarachchi, Daya, Russek-Cohen, Estelle, Gutman, Steven I
Published in Human genomics (01.01.2006)
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Best practices for benchmarking germline small-variant calls in human genomes
Krusche, Peter, Trigg, Len, Boutros, Paul C., Mason, Christopher E., De La Vega, Francisco M., Moore, Benjamin L., Gonzalez-Porta, Mar, Eberle, Michael A., Tezak, Zivana, Lababidi, Samir, Truty, Rebecca, Asimenos, George, Funke, Birgit, Fleharty, Mark, Chapman, Brad A., Salit, Marc, Zook, Justin M.
Published in Nature biotechnology (01.05.2019)
Published in Nature biotechnology (01.05.2019)
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Statistical Design for Biospecimen Cohort Size in Proteomics-based Biomarker Discovery and Verification Studies
Skates, Steven J, Gillette, Michael A, LaBaer, Joshua, Carr, Steven A, Anderson, Leigh, Liebler, Daniel C, Ransohoff, David, Rifai, Nader, Kondratovich, Marina, Težak, Živana, Mansfield, Elizabeth, Oberg, Ann L, Wright, Ian, Barnes, Grady, Gail, Mitchell, Mesri, Mehdi, Kinsinger, Christopher R, Rodriguez, Henry, Boja, Emily S
Published in Journal of proteome research (06.12.2013)
Published in Journal of proteome research (06.12.2013)
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Analytical Validation of Protein-Based Multiplex Assays: A Workshop Report by the NCI-FDA Interagency Oncology Task Force on Molecular Diagnostics
Rodriguez, Henry, Tezak, Zivana, Mesri, Mehdi, Carr, Steven A, Liebler, Daniel C, Fisher, Susan J, Tempst, Paul, Hiltke, Tara, Kessler, Larry G, Kinsinger, Christopher R, Philip, Reena, Ransohoff, David F, Skates, Steven J, Regnier, Fred E, Anderson, N. Leigh, Mansfield, Elizabeth, on behalf of Workshop Participants
Published in Clinical chemistry (Baltimore, Md.) (01.02.2010)
Published in Clinical chemistry (Baltimore, Md.) (01.02.2010)
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Protein-Based Multiplex Assays: Mock Presubmissions to the US Food and Drug Administration
Regnier, Fred E, Skates, Steven J, Mesri, Mehdi, Rodriguez, Henry, Tezak, Zivana, Kondratovich, Marina V, Alterman, Michail A, Levin, Joshua D, Roscoe, Donna, Reilly, Eugene, Callaghan, James, Kelm, Kellie, Brown, David, Philip, Reena, Carr, Steven A, Liebler, Daniel C, Fisher, Susan J, Tempst, Paul, Hiltke, Tara, Kessler, Larry G, Kinsinger, Christopher R, Ransohoff, David F, Mansfield, Elizabeth, Anderson, N. Leigh
Published in Clinical chemistry (Baltimore, Md.) (01.02.2010)
Published in Clinical chemistry (Baltimore, Md.) (01.02.2010)
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Author Correction: Best practices for benchmarking germline small-variant calls in human genomes
Krusche, Peter, Trigg, Len, Boutros, Paul C., Mason, Christopher E., De La Vega, Francisco M., Moore, Benjamin L., Gonzalez-Porta, Mar, Eberle, Michael A., Tezak, Zivana, Lababidi, Samir, Truty, Rebecca, Asimenos, George, Funke, Birgit, Fleharty, Mark, Chapman, Brad A., Salit, Marc, Zook, Justin M.
Published in Nature biotechnology (01.05.2019)
Published in Nature biotechnology (01.05.2019)
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Toward best practice in cancer mutation detection with whole-genome and whole-exome sequencing
Xiao, Wenming, Ren, Luyao, Chen, Zhong, Fang, Li Tai, Zhao, Yongmei, Lack, Justin, Guan, Meijian, Zhu, Bin, Jaeger, Erich, Kerrigan, Liz, Blomquist, Thomas M., Hung, Tiffany, Sultan, Marc, Idler, Kenneth, Lu, Charles, Scherer, Andreas, Kusko, Rebecca, Moos, Malcolm, Xiao, Chunlin, Sherry, Stephen T., Abaan, Ogan D., Chen, Wanqiu, Chen, Xin, Nordlund, Jessica, Liljedahl, Ulrika, Maestro, Roberta, Polano, Maurizio, Drabek, Jiri, Vojta, Petr, Kõks, Sulev, Reimann, Ene, Madala, Bindu Swapna, Mercer, Timothy, Miller, Chris, Jacob, Howard, Truong, Tiffany, Moshrefi, Ali, Natarajan, Aparna, Granat, Ana, Schroth, Gary P., Kalamegham, Rasika, Peters, Eric, Petitjean, Virginie, Walton, Ashley, Shen, Tsai-Wei, Talsania, Keyur, Vera, Cristobal Juan, Langenbach, Kurt, de Mars, Maryellen, Hipp, Jennifer A., Willey, James C., Wang, Jing, Shetty, Jyoti, Kriga, Yuliya, Raziuddin, Arati, Tran, Bao, Zheng, Yuanting, Yu, Ying, Cam, Margaret, Jailwala, Parthav, Nguyen, Cu, Meerzaman, Daoud, Chen, Qingrong, Yan, Chunhua, Ernest, Ben, Mehra, Urvashi, Jensen, Roderick V., Jones, Wendell, Li, Jian-Liang, Papas, Brian N., Pirooznia, Mehdi, Chen, Yun-Ching, Seifuddin, Fayaz, Li, Zhipan, Liu, Xuelu, Resch, Wolfgang, Wang, Jingya, Wu, Leihong, Yavas, Gokhan, Miles, Corey, Ning, Baitang, Tong, Weida, Mason, Christopher E., Donaldson, Eric, Lababidi, Samir, Staudt, Louis M., Tezak, Zivana, Hong, Huixiao, Wang, Charles, Shi, Leming
Published in Nature biotechnology (01.09.2021)
Published in Nature biotechnology (01.09.2021)
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The MicroArray Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive models
Shi, Leming, Campbell, Gregory, Jones, Wendell D, Campagne, Fabien, Wen, Zhining, Walker, Stephen J, Su, Zhenqiang, Chu, Tzu-Ming, Goodsaid, Federico M, Pusztai, Lajos, Shaughnessy, Jr, John D, Oberthuer, André, Thomas, Russell S, Paules, Richard S, Fielden, Mark, Barlogie, Bart, Chen, Weijie, Du, Pan, Fischer, Matthias, Furlanello, Cesare, Gallas, Brandon D, Ge, Xijin, Megherbi, Dalila B, Symmans, W Fraser, Wang, May D, Zhang, John, Bitter, Hans, Brors, Benedikt, Bushel, Pierre R, Bylesjo, Max, Chen, Minjun, Cheng, Jie, Cheng, Jing, Chou, Jeff, Davison, Timothy S, Delorenzi, Mauro, Deng, Youping, Devanarayan, Viswanath, Dix, David J, Dopazo, Joaquin, Dorff, Kevin C, Elloumi, Fathi, Fan, Jianqing, Fan, Shicai, Fan, Xiaohui, Fang, Hong, Gonzaludo, Nina, Hess, Kenneth R, Hong, Huixiao, Huan, Jun, Irizarry, Rafael A, Judson, Richard, Juraeva, Dilafruz, Lababidi, Samir, Lambert, Christophe G, Li, Li, Li, Yanen, Li, Zhen, Lin, Simon M, Liu, Guozhen, Lobenhofer, Edward K, Luo, Jun, Luo, Wen, McCall, Matthew N, Nikolsky, Yuri, Pennello, Gene A, Perkins, Roger G, Philip, Reena, Popovici, Vlad, Price, Nathan D, Qian, Feng, Scherer, Andreas, Shi, Tieliu, Shi, Weiwei, Sung, Jaeyun, Thierry-Mieg, Danielle, Thierry-Mieg, Jean, Thodima, Venkata, Trygg, Johan, Vishnuvajjala, Lakshmi, Wang, Sue Jane, Wu, Jianping, Wu, Yichao, Xie, Qian, Yousef, Waleed A, Zhang, Liang, Zhang, Xuegong, Zhong, Sheng, Zhou, Yiming, Zhu, Sheng, Arasappan, Dhivya, Bao, Wenjun, Lucas, Anne Bergstrom, Berthold, Frank, Brennan, Richard J, Buness, Andreas, Catalano, Jennifer G, Chang, Chang, Chen, Rong, Cheng, Yiyu
Published in Nature biotechnology (01.08.2010)
Published in Nature biotechnology (01.08.2010)
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FDA Approval Summary: Selpercatinib for the treatment of advanced RET fusion-positive solid tumors
Duke, Elizabeth S, Bradford, Diana, Marcovitz, Michelle, Amatya, Anup K, Mishra-Kalyani, Pallavi S, Nguyen, Emily, Price, Lauren S L, Fourie Zirkelbach, Jeanne, Li, Yangbing, Bi, Youwei, Kraft, Jeffrey, Dorff, Sarah E, Scepura, Barbara, Stephenson, Maritsa, Ojofeitimi, Idara, Nair, Abhilasha, Han, Yu, Tezak, Zivana, Lemery, Steven J, Pazdur, Richard, Larkins, Erin, Singh, Harpreet
Published in Clinical cancer research (15.09.2023)
Published in Clinical cancer research (15.09.2023)
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Resource requirements to accelerate clinical applications of next generation sequencing and radiomics: Workshop commentary and review
Harris, Lyndsay, Shankar, Lalitha K, Hildebrandt, Claire, Rubinstein, Wendy S, Langlais, Kristofor, Rodriguez, Henry, Berger, Adam, Freymann, John, Huang, Erich P, Williams, P Mickey, Claude Zenklusen, Jean, Ochs, Robert, Tezak, Zivana, Sahiner, Berkman
Published in JNCI : Journal of the National Cancer Institute (01.10.2024)
Published in JNCI : Journal of the National Cancer Institute (01.10.2024)
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Establishing community reference samples, data and call sets for benchmarking cancer mutation detection using whole-genome sequencing
Fang, Li Tai, Zhu, Bin, Zhao, Yongmei, Chen, Wanqiu, Yang, Zhaowei, Kerrigan, Liz, Langenbach, Kurt, de Mars, Maryellen, Lu, Charles, Idler, Kenneth, Jacob, Howard, Zheng, Yuanting, Ren, Luyao, Yu, Ying, Jaeger, Erich, Schroth, Gary P., Abaan, Ogan D., Talsania, Keyur, Lack, Justin, Shen, Tsai-Wei, Chen, Zhong, Stanbouly, Seta, Tran, Bao, Shetty, Jyoti, Kriga, Yuliya, Meerzaman, Daoud, Nguyen, Cu, Petitjean, Virginie, Sultan, Marc, Cam, Margaret, Mehta, Monika, Hung, Tiffany, Peters, Eric, Kalamegham, Rasika, Sahraeian, Sayed Mohammad Ebrahim, Mohiyuddin, Marghoob, Guo, Yunfei, Yao, Lijing, Song, Lei, Lam, Hugo Y. K., Drabek, Jiri, Vojta, Petr, Maestro, Roberta, Gasparotto, Daniela, Kõks, Sulev, Reimann, Ene, Scherer, Andreas, Nordlund, Jessica, Liljedahl, Ulrika, Jensen, Roderick V., Pirooznia, Mehdi, Li, Zhipan, Xiao, Chunlin, Sherry, Stephen T., Kusko, Rebecca, Moos, Malcolm, Donaldson, Eric, Tezak, Zivana, Ning, Baitang, Tong, Weida, Li, Jing, Duerken-Hughes, Penelope, Catalanotti, Claudia, Maheshwari, Shamoni, Shuga, Joe, Liang, Winnie S., Keats, Jonathan, Adkins, Jonathan, Tassone, Erica, Zismann, Victoria, McDaniel, Timothy, Trent, Jeffrey, Foox, Jonathan, Butler, Daniel, Mason, Christopher E., Hong, Huixiao, Shi, Leming, Wang, Charles, Xiao, Wenming
Published in Nature biotechnology (01.09.2021)
Published in Nature biotechnology (01.09.2021)
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FDA Approval Summary: Selpercatinib for the Treatment of Advanced RET Fusion-Positive Solid Tumors
Duke, Elizabeth S, Bradford, Diana, Marcovitz, Michelle, Amatya, Anup K, Mishra-Kalyani, Pallavi S, Nguyen, Emily, Price, Lauren S L, Fourie Zirkelbach, Jeanne, Li, Yangbing, Bi, Youwei, Kraft, Jeffrey, Dorff, Sarah E, Scepura, Barbara, Stephenson, Maritsa, Ojofeitimi, Idara, Nair, Abhilasha, Han, Yu, Tezak, Zivana, Lemery, Steven J, Pazdur, Richard, Larkins, Erin, Singh, Harpreet
Published in Clinical cancer research (15.09.2023)
Published in Clinical cancer research (15.09.2023)
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A research roadmap for next-generation sequencing informatics
Altman, Russ B, Prabhu, Snehit, Sidow, Arend, Zook, Justin M, Goldfeder, Rachel, Litwack, David, Ashley, Euan, Asimenos, George, Bustamante, Carlos D, Donigan, Katherine, Giacomini, Kathleen M, Johansen, Elaine, Khuri, Natalia, Lee, Eunice, Liang, Xueying Sharon, Salit, Marc, Serang, Omar, Tezak, Zivana, Wall, Dennis P, Mansfield, Elizabeth, Kass-Hout, Taha
Published in Science translational medicine (20.04.2016)
Published in Science translational medicine (20.04.2016)
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